The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition

Kamuzu University of Health Sciences

Status: Not yet enrolling

Conditions: Amino Acid, Stunting, Environmental Enteric Dysfunction

Treatments: Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06617130

P.02/23/3992

Details and patient eligibility

About

A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with provision of standard complementary food without IAA in healthy Malawian children aged 18-36 months with or without stunting.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/exclusion criteria assessment, consent, and randomization.

In order to be eligible to participate in the study, an individual must meet all of the following criteria:

1. 18-36 months old (now agreed to by all countries)
2. Stunted (LAZ<-2)
3. Of either sex
4. Able and willing to undergo HIV testing
5. Parent, carer, or guardian able and willing to give written, informed consent
6. A positive HIV test result will not be an exclusion criterion.

Exclusion criteria

• An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Under 18 months of age
  2. Over 36 months old
  3. Wasted (weight-for-length Z-score less than -2)
  4. Overweight (weight-for-length Z-score greater than 2)
  5. Have had diarrhea (by self-report) in the preceding month
  6. Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
  7. Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

corn soy bean flour porridge with added indespensable amino acids

Active Comparator group

Description:

Children in the intervention arm will receive corn-soy blended flour porridge mixed with IAA. The CSB flour will be packed in 1kg packets while the IAA will be packed in small plastic bags. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. Pre-weighed IAA will be provided so that mothers can mix the IAA to the prepared CSB porridge. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.

Treatment:

Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid

Corn soy bean flour porridge

Other group

Description:

Children in the control arm children will receive corn-soy blended flour porridge only. The CSB flour will be packed in 1kg packets. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.

Treatment:

Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid